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Clinical Trials/NCT04998526
NCT04998526UnknownNot Applicable

The Effect of Local Cold Application on Hypertension

Ataturk University1 site in 1 country72 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
72
Locations
1
Primary Endpoint
Blood pressure

Study Overview

Brief Summary

This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.

Detailed Description

Aim: This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.

Material and method: This study, which is planned as a randomized controlled and experimental study, will be conducted with type 2 (systolic blood pressure between 160 and 179 mmHg, diastolic blood pressure between 100 and 109 mmHg) essential hypertension patients who refer to Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service. The patients will be distributed as 24 in experimental group, 24 in placebo group and 24 in control group based on block randomization (gender and age) method and a total of 72 patients will be included. Patient information form, blood pressure and heart rate monitoring form and VAS pain scale will be used to collect study data. Patients in all groups will be measured in 90 minutes for a total of 8 times, as pre-test (pre-application) and post-test (minutes 3, 10, 15, 20, 30, 60 and 90). After routine medication therapy is given to all three groups, the cold gel pack which has been kept at least for four hours in the freezer will be applied to the nape of the patients in the experimental group, while gel pack at room temperature will be applied to the placebo group and no application will be made to the control group. Variance analysis, Friedman analysis, t test, Wilcoxon test and Kruskal Wallis analysis will be used in data assessment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •25 mg sublingual ACE inhibitor given as a treatment protocol,
  • •No wound on the nape,
  • •Does not develop cold intolerance,
  • •Not taking any hypertension medication and pain medication in the last 6 hours,
  • •Without heart diseases, peripheral arterial circulation disorders, sensory disorders and edema,
  • •Not pregnant,
  • •Agreeing to participate in the study,
  • •Essential hypertension patients with systolic blood pressure 160 - 179 mmHg, diastolic blood pressure 100 - 109 mmHg.

Exclusion Criteria

  • •Developing cold intolerance,
  • •Changes in the treatment regimen,
  • •Panic attack, allergic reaction and any similar situation develops,
  • •Those who want to withdraw from the research

Arms & Interventions

Experimental group

Experimental

After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes.

Intervention: Experimental group (Other)

Placebo group

Placebo Comparator

After routine drug therapy is given to hypertension patients, the gel pack kept at room temperature will be applied to the nape for 3 minutes.

Intervention: Placebo group (Other)

Control group

No Intervention

Routine drug treatment will be given to hypertension patients and no application will be made.

Outcomes

Primary Outcomes

Blood pressure

Time Frame: 90 minute

Lowering blood pressure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

YAVUZ ÜREN

PhD Student

Ataturk University

Study Sites (1)

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